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4-drug Nerve Block Versus Plain Local Anesthetic for Knee and Hip Arthroplasty Analgesia in Veterans

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ClinicalTrials.gov Identifier: NCT02891798
Recruitment Status : Recruiting
First Posted : September 8, 2016
Last Update Posted : May 14, 2019
Sponsor:
Collaborator:
University of Pittsburgh
Information provided by (Responsible Party):
Brian Williams, VA Pittsburgh Healthcare System

Brief Summary:
After total joint replacement, early hospital discharge to home (with patients capable of continuing a home-based rehabilitation program) is a cost- effective management strategy. This project will use improved local anesthetic nerve block techniques to enhance technical capability and clinical practice by (i) reducing pain and other morbidities during recovery, (ii) improving weight-bearing achievement during in-hospital physical therapy to allow for earlier return home, and (iii) continued rehabilitation as an outpatient at home when feasible (versus in an extended care facility).

Condition or disease Intervention/treatment Phase
Pain Drug: Bupivacaine + CBD (clonidine, buprenorphine, dexamethasone) Drug: Bupivacaine Only (control arm) Phase 3

Detailed Description:
Patients will have spinal anesthesia for their hip or knee replacement surgery. They will also receive the nerve blocks described above

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 4-drug Nerve Block Versus Plain Local Anesthetic for Knee and Hip Arthroplasty Analgesia in Veterans
Study Start Date : October 2016
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : April 2020


Arm Intervention/treatment
Experimental: Bupivacaine + CBD (clonidine, buprenorphine, dexamethasone)
Patients will receive a nerve block consisting of bupivacaine plus clonidine-buprenorphine-dexamethasone (Bupivacaine-CBD)
Drug: Bupivacaine + CBD (clonidine, buprenorphine, dexamethasone)
Nerve blocks before surgery of L2-L4 and L4-S3 for Knee replacements Nerve blocks before surgery of L2-L4 for hip replacements
Other Name: "Marcaine" + CBD (clonidine, buprenorphine, dexamethasone)

Active Comparator: Bupivacaine Only (control arm)
Patients will receive a nerve block consisting of bupivacaine only.
Drug: Bupivacaine Only (control arm)
Nerve blocks before surgery of L2-L4 and L4-S3 for Knee replacements Nerve blocks before surgery of L2-L4 for hip replacements
Other Name: Marcaine




Primary Outcome Measures :
  1. Short-Form McGill Pain Questionnaire (version 2) [ Time Frame: 24 hours post surgery ]
    SF-MPQ version 2


Secondary Outcome Measures :
  1. Performed-based physical function is assessed using timed tests such as the 'standing balance test', the 'self-selected gait speed test', and the 'repeated chair stand test' [ Time Frame: Post-op days 1-5 and 6 weeks post-op ]
    These tests are germane to subjects with total joint replacement that are easily performed in the clinical settings. The tests will capture the domains of muscle strength and activation, balance, and ability to walk.

  2. Anesthesia-related symptoms [ Time Frame: Post-op days 1-5, 2 weeks post-op and 6 weeks post-op ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age between 18 and 85, and undergoing a total knee or hip replacement.
  2. Fluent in English, decision competent, willing and able to provide written informed consent, and able to complete the study's schedule of assessments.
  3. Able to walk >3m without an assisting device.
  4. Have a BMI ≤ 40 kg/m2.

Exclusion Criteria:

  1. Current participation in another orthopedic/Physical Therapy/rehab/anesthesiology interventional clinical trial.
  2. Are at significant behavioral risks or have refractory major psychiatric disorders.
  3. Revision surgery on the same extremity.
  4. Have an American Surgical Association (ASA) Physical Status classification of 4 or higher.
  5. Have been diagnosed with clinically significant neuropathy with its origins in either diabetes or other causes; have neuromuscular disease that would influence data collection.
  6. Have a surgically-fused lumbar spine, or a spinal cord simulator, or other condition that would contraindicate or prohibit the conduct of spinal anesthesia.
  7. At significant risk for postoperative substance abuse, or immediate-postoperative substance abuse withdrawal symptoms (alcohol, cocaine, enrolled in methadone or buprenorphine opioid withdrawal programs, etc.) Previous or current use of marijuana will not be an exclusion for study enrollment.
  8. Are undergoing Total Knee Arthroplasty (TKA)/Total Hip Arthroplasty (THA) for a tumor.
  9. Have contraindications (e.g., anaphylaxis) to any of the study drugs.
  10. Have a systemic fungal infection.
  11. Have a known hypersensitivity to bupivacaine hydrochloride or to any local anesthetic of the amide-type or to other components of bupivacaine hydrochloride solutions.
  12. Have a known or suspected buprenorphine hypersensitivity (not including nausea and/or vomiting).
  13. Have a gastro-intestinal (GI) obstruction.
  14. Have paralytic ileus.
  15. Pregnant women
  16. Have had a kidney or liver transplant.

Veterans will not be excluded from participation based on smoking status, diagnosis of obstructive sleep apnea, or baseline monitored consumption of therapeutic opioids for documented medical indications; instead, these variables will be codified and quantified for subsequent covariate statistical analysis.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02891798


Contacts
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Contact: Karen Gilbert 412-360-6666 karen.gilbert2@va.gov
Contact: Samantha Bonant, MS, CCRP 412-360-3788 samantha.bonant@va.gov

Locations
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United States, Pennsylvania
VA Pittsburgh Healthcare System Recruiting
Pittsburgh, Pennsylvania, United States, 15240
Contact: Karen Gilbert    412-360-6666    karen.gilbert2@va.gov   
Contact: Samantha Bonant, MS, CCRP    412-360-3788    samantha.bonant@va.gov   
Principal Investigator: Brian Williams, MD, MBA         
Sub-Investigator: James Ibinson, MD         
Sub-Investigator: Visala Muluk, MD         
Sub-Investigator: Catalin Ezaru, MD         
Sub-Investigator: Marsha RitterJones, MD         
Sponsors and Collaborators
Brian Williams
University of Pittsburgh
Investigators
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Principal Investigator: Brian Williams, MD, MBA VA Pittsburgh Healthcare System

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Responsible Party: Brian Williams, VAPHS Surgical Specialties Service Line Medical Director, VA Pittsburgh Healthcare System
ClinicalTrials.gov Identifier: NCT02891798     History of Changes
Other Study ID Numbers: PRO 1357
13232002 ( Other Identifier: USARMC )
First Posted: September 8, 2016    Key Record Dates
Last Update Posted: May 14, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Brian Williams, VA Pittsburgh Healthcare System:
analgesia,
buprenorphine
clonidine
dexamethasone
bupivacaine
nerve block

Additional relevant MeSH terms:
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Dexamethasone
Dexamethasone acetate
Clonidine
Buprenorphine
Bupivacaine
Anesthetics, Local
Anesthetics
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Depressants
Sensory System Agents
Analgesics, Opioid
Narcotics
Analgesics
Narcotic Antagonists
Antihypertensive Agents
Sympatholytics